A method of containing, lyophilizing, reconstituting and administering lyophilized substances is already known.
For example, patent specification U.S. Pat. No. 5,637,087 A discloses a sealed first substance container containing a lyophilized substance. This substance container can optionally be inserted in an applicator together with a second container containing an injection fluid. By means of a support with a double-ended needle between the two containers which is mounted so that it can slide in the hollow barrel of the applicator, a fluid connection can be established between the first and second containers so that the fluid from the first container can be forced into the substance container under the action of a plunger also disposed in the barrel chamber of the applicator. Once the injection fluid has been forced into the substance container, the plunger can be pushed further into the cylindrical interior of the applicator to establish a line connection to an outlet which can be connected to an injection needle so that the reconstituted substance can be administered immediately it has been reconstituted. The disadvantage of this applicator is the fact that elastically deformable containers are needed and a few needle inserts also have to be provided.
DE 696 30 444 T2 also discloses the idea of using an applicator part as a housing compartment for the substance and the substance is lyophilized in this applicator part and stored in the lyophilized state.
At its output-side front housing end, this housing compartment is provided with a removable closure with a Luer lock fitting and its end remote from the front housing is sealed by means of a plunger in conjunction with an adapter inserted in it. The adapter is of a two-part design and comprises two tubular parts guided one inside the other, and the outer part is mounted so that it can slide along the internal wall of the housing compartment, whilst the inner tubular part is screwed into the outer tubular part by means of a thread and closes off an orifice in the plunger opening into the housing compartment in which the lyophilised substance is contained. The inner part can be screwed off and an injection device filled with a diluent can be screwed on instead. By forcing the injection substance out of this injection device into the housing compartment for the lyophilized substance, the latter can be reconstituted, and the outer part of the closure adapter can be moved back in the direction of the open end of the housing compartment by forcing the diluent into the housing compartment of the substance to be lyophilized, and the plunger closing the housing compartment is moved forward so that it lies against the end face of the injection device facing the housing compartment, and once the closure on the front housing has been opened and an injection needle inserted, which causes the substance in the housing compartment for the reconstituted substance to be vented, the substance can then be injected. The disadvantage of this system is that it requires the use of a separate closure adapter and the operation of removing it and inserting the injection device containing the diluent takes time.
Other pre-filled ready to use syringes containing a lyophilizate and diluent whereby the lyophilization process takes place in the syringe are known from U.S. Pat. No. 6,440,101 B1, DE 39 24 830 A1, DE 196 38 940 A1, DE 41 27 650 C1 and DE 197 150 226 C.